Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

Khyber Medical University Peshawar

Status: Enrolling

Conditions: Intermediate Hyperglycemia (IHG); Type II Diabetes Mellitus

Treatments: Behavioral: Participatory, Learning and Action Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06561126

KMU/DIR/CTU/2024/007

NIHR203248 (Other Grant/Funding Number)

Details and patient eligibility

About

This project aims to adapt, implement, and evaluate Participatory Learning and Action (PLA) based intervention in rural areas of KPK, Pakistan which includes Peshawar and Swabi for TIIDM prevention and control. The pivotal components of this approach include adapting, implementing, and evaluating the PLA-based intervention for the prevention and control of Type II diabetes. These components will be tailored to meet the specific needs of two different settings in Peshawar and Swabi, Pakistan.

Type II Diabetes Mellitus (TIIDM) is considered the fastest-growing health emergency, affecting 537 million adults worldwide. Global projections for the year 2045 suggest that a 12.2% rise in TIIDM is anticipated with an additional 11.4% rise for intermediate hyperglycemia (IHG) [1]. Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system [2]. The intervention "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" has been tested and found effective in the rural context of Bangladesh [1-3]. A full trial will be conducted in the rural areas of Peshawar and Swabi, Pakistan.

It is anticipated that with the use of evidence-based approaches, best practices, and meaningful community participation, PLA is expected to enhance social and behavioural determinants of health and subsequent outcomes. This will further pave the way for the control of other NCDs through a similar focused approach.

Full description

The PLA approach has been systematized into a community approach where groups meet together and follow a cycle of activities. This cycle involves problem identification, collaborative strategy planning, implementation, and participatory evaluation. To address community health issues, various strategies including photo voice, group discussions, and role-play have been widely utilized. By leveraging their life experiences, individuals are encouraged to actively participate in these activities, empowering them to identify problems and utilize their skills to develop effective solutions.

Scientific evidence has demonstrated PLA to be a cost-effective technique to increase maternal and neonatal survival in low-resource settings like India and Nepal. Moreover, it increased awareness about birth preparedness, improved newborn care practices, and enhanced male participation in maternal and newborn health.

This study will utilize a community group-based PLA approach to tackle TIIDM (adapted from D-Magic Bangladesh). A cluster randomized controlled trial will be conducted to assess the effectiveness of PLA in addressing TIIDM and pre-diabetes in rural areas of Peshawar and Swabi, Pakistan. The PLA approach is instrumental in improving health outcomes and services by fostering collaborative community efforts and empowering the community. This collaborative approach fosters a sense of unity, inclusivity, and shared responsibility, ultimately contributing to improved health outcomes and the overall well-being of the community. However, despite its significant impact PLA has not been adapted or tested in settings elsewhere for the prevention and control of TIIDM.

Objective:

1. To culturally adapt PLA-based intervention (DMagic) for primary prevention and control of TIIDM in rural communities of Pakistan.
2. To assess the effectiveness of culturally adapted PLA-based intervention (adapted from D-Magic trial Bangladesh) on the two-year cumulative incidence of TIIDM in high-risk individuals and the prevalence of IHG and TIIDM in rural settings.
3. To determine the cost-effectiveness of the adapted DMagic intervention in rural settings of Pakistan.

Enrollment: 12,744 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals aged 20 years and above.
• Participants residing in the rural areas of Peshawar and Swabi, Pakistan.
• Individuals willing to participate in the study and provide consent.
• Both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate.
• Participants who can attend the scheduled meetings and interventions as per the study protocol.

Exclusion criteria

• Individuals below the age of 20 years.
• Individuals unwilling to provide consent for participation.
• Participants with severe health conditions that may hinder their active involvement in the study.
• Individuals with a history of non-compliance with medical interventions or research protocols

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,744 participants in 2 patient groups

Participatory, Learning and Action (PLA) Based Intervention

Experimental group

Description:

Community mobilization will be done via male and female community groups using a PLA Cycle whereby groups themselves identify and priorities problems associated with diabetes and the risk of developing diabetes.Lay facilitators will convene the groups monthly over a period of 18 months, with one meeting per month. A total of 64 groups will be established in each district, each comprising approximately 20-30 participants, covering an eligible population of 250 to 300 individuals. The total number of participants exposed to the intervention, adapted from the DMagic trial in Bangladesh, will be determined based on random selection from the community. The intervention will focus on participatory groups, with separate groups for males and females to ensure inclusivity and encourage participation from high-risk individuals and those with TIIDM.

Treatment:

Behavioral: Participatory, Learning and Action Based Intervention

Usual Care

No Intervention group

Description:

The Control Group will not receive the PLA (Participatory Learning and Action) intervention. Study participants in the control group would not be exposed to the training and would be kept in the control group. They would be a group that would receive usual care and routine awareness. However, they will still benefit from the study in several ways. Information about the trial and guidance on who to contact in case of hyperglycemia or intermediate hyperglycemia will be provided. The disease burden in the control area will be monitored, and findings will be included in national and international advocacy and dissemination efforts.